Theracare Ice Blue Gel

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician before using this product.

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated with other topical pain relievers due to the potential for increased adverse effects. The application of heating pads or heating devices concurrently is also contraindicated, as this may lead to excessive heat and skin irritation.

Contact with the eyes must be avoided to prevent irritation or injury. Additionally, tight bandaging of the application site is contraindicated, as it may restrict blood flow and exacerbate local reactions. The product should not be applied to wounds or damaged skin, as this may lead to further complications or systemic absorption.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

When utilizing this product, several precautions must be observed to ensure safe and effective use. It is advised to avoid concurrent use with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of heating pads or other heating devices in conjunction with this product should be avoided, as this may exacerbate skin irritation or discomfort. Care should be taken to prevent contact with the eyes, as this may lead to significant irritation. Bandaging should not be applied tightly over the area of application, and the product should not be used on wounds or damaged skin to prevent further complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical consultation is also recommended.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional before using this product.

Drug Interactions

The concomitant use of this product with other topical pain relievers may lead to an increased risk of adverse effects. It is advisable to monitor the patient closely for any signs of enhanced local irritation or systemic effects when these products are used together.

Additionally, the application of this product in conjunction with heating pads or other heating devices may enhance the absorption of the active ingredients, potentially leading to increased efficacy but also a heightened risk of local irritation or burns. Caution is recommended, and patients should be advised to avoid excessive heat application.

No specific interactions with laboratory tests have been identified for this product.

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Ice Blue Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before using this product. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed.

When using this product, it is important to inform patients that they should not use it in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, patients should be cautioned against using heating pads or any heating devices while applying this product, as this could lead to increased irritation or burns.

Patients must be instructed to avoid contact with the eyes to prevent irritation or injury. They should also be advised not to bandage the area tightly after application, as this may impede circulation and exacerbate side effects. Furthermore, patients should refrain from applying the product to wounds or damaged skin to avoid complications.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using this product to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in a container that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. Additionally, it is crucial to avoid using, pouring, spilling, or storing the product near heat sources or open flames to prevent any potential hazards.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Theracare Ice Blue Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)